Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial (GOAL-BP)
The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.
Researchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future.
Participants will:
- Be assigned by chance to one of the two blood pressure goals.
- Have their blood pressure measured at clinic visits about every two weeks.
- Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal.
- Be part of the study for about four and a half months.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Peritoneal dialysis (PD) use among patients with end-stage kidney disease (ESKD) has increased substantially over the last decade. Yet there are no randomized clinical trials evaluating blood pressure (BP) targets in patients receiving PD.
GOAL-BP is a pilot study that will evaluate the feasibility of enrolling patients receiving PD to two systolic blood pressure targets (SBP): <120mmHg vs. <140 mmHg.
BP management will be guided by standardized clinic measurements. The study team will make recommendations to the treating nephrologist to achieve the goal SBP using a stepwise approach that addresses volume status before recommending changes to antihypertensive medications. The treating nephrologist will make the final decision about any changes to clinical care.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: Kashvi.Gupta@ucsf.edu
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94110
- Har ikke rekruttert ennå
- Zuckerberg San Francisco General Hospital
-
Ta kontakt med:
- Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: kashvi.gupta@ucsf.edu
-
San Francisco, California, Forente stater, 94014
- Rekruttering
- Satellite Healthcare - Daly City
-
Ta kontakt med:
- Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: kashvi.gupta@ucsf.edu
-
San Francisco, California, Forente stater, 94118
- Rekruttering
- Satellite Healthcare - San Francisco Geary
-
Ta kontakt med:
- Kashvi Gupta, MD, MPH
- Telefonnummer: 734-546-4545
- E-post: kashvi.gupta@ucsf.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years.
- Undergoing regular PD for treatment of ESKD.
- On PD for ≥ 4 months. (We do not plan to enroll patients within the first 3 months of PD initiation because there can be large fluctuations in volume status and BP readings before patient coming into more of a steady state. We then require participants to have at least 1 month of BP data to allow calculation of an average pre-enrollment BP for screening for study entry.)
- Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening.
- Able to measure brachial BP.
Exclusion Criteria:
- Planned transplant or HD transition < 4.5 months (the duration of study).
- Estimated life expectancy < 4.5 months (also determined by asking the treating nephrologist).
- Participation in another clinical trial that may affect BP management.
- Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis.
- Incarceration or institutionalized living which may prohibit measurement of home BP.
- Presence of a condition or abnormality that, in the opinion of the study team or treating nephrologist, would compromise the safety of the patient or the quality of the data.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Intervention
Target systolic blood pressure <120 mmHg |
The target SBP <120 mmHg will be operationalized as SBP 100-119 mmHg in the intervention arm. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain SBP <120 mmHg in the interventional arm. If SBP were <100 mmHg at one visit or <105 mmHg at two consecutive visits, BP medications will be reduced to keep SBP in the range of 100 to 119 mmHg, to avoid hypotensive episodes. |
|
Annen: Control
Target systolic blood pressure <140 mmHg |
The target SBP <140 mmHg will be operationalized as SBP 130-139 mmHg. For volume control, the patient's dry weight target will be adjusted downward and will be attempted to be achieved through greater PD ultrafiltration, dietary fluid/salt restriction, or diuretics. Once patients are deemed euvolemic based on the assessment of the treating nephrologist, antihypertensive medications will be added or adjusted in a standardized sequence: priority is given to angiotensin-converting enzyme inhibitors (ACE inhibitors) or angiotensin receptor blockers (ARBs) due to data about this class of agents being shown to better preserve residual kidney function. Other medications are recommended to be added as indicated to maintain <140 mmHg in the control arm. If SBP were <130 mmHg at one visit or <135 mmHg at two consecutive visits, BP medications will be tapered/discontinued to keep SBP in the range of 130 to 139 mmHg. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of enrolling participants
Tidsramme: 4.5 months
|
The primary feasibility endpoint is the screen-to-enrollment ratio, calculated as the number of participants randomized divided by the number of potentially eligible individuals screened during the recruitment period. Physician refusal and patient refusal rates will also be reported. |
4.5 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Retention of study participants
Tidsramme: 4.5 months
|
The duration a study participant will be in the study, from the baseline visit. |
4.5 months
|
|
Physician adherence to protocol recommendations for achieving target SBP
Tidsramme: 4.5 months
|
4.5 months
|
|
|
Patient adherence to home BP measurements and recommended adjustments in dialysis prescription and medications
Tidsramme: 4.5 months
|
Adherence will be assessed by the number of times a patient follows the recommendations across BP measurements, changes in dialysis prescription, and medications. |
4.5 months
|
|
SBP achieved in each arm
Tidsramme: 4.5 months
|
4.5 months
|
|
|
Change in residual kidney function under two different SBP targets
Tidsramme: 4.5 months
|
Residual kidney function is assessed by 24-hour urine collection as per the dialysis unit protocol and indication. These will be assessed to determine any changes. |
4.5 months
|
|
Safety of targeting SBP <120 mmHg vs. <140 mmHg
Tidsramme: 4.5 months
|
4.5 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Qualitative themes identified from the end-of-study structured participant interviews
Tidsramme: 4.5 months
|
Structured participant interviews will be administered by the study team to the patient to collect qualitative feedback, which will be organized into themes. |
4.5 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Chi-yuan Hsu, MD, MS, University of California, San Francisco
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Nyresvikt, kronisk
- Patologiske tilstander, tegn og symptomer
- Hypertensjon
- Nyresvikt, kronisk
Andre studie-ID-numre
- STUDY00000009
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